Orthonika, a MedTech spin-out from Imperial College London, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its novel Total Meniscus Replacement (TMR) implant. The company has also been invited to participate in the FDA’s Total Product Life Cycle Advisory Program (TAP), designed to accelerate the development and commercialisation [...]The post FDA grants breakthrough designation to Orthonika’s synthetic total meniscus implant appeared first on Med-Tech Insights.
FDA grants breakthrough designation to Orthonika’s synthetic total meniscus implant